Quality specialist III
Thermo Fisher Scientific
Summary
In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.
Job description
Position Summary
In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.
Key Responsibilities
- Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
- Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
- Champions quality culture by aiding personnel in understanding application of policies and controls
- Participate in RAPID event response and provides quality guidance for deviation events
- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
- Performs quality batch record review
- Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
- Support client quality interactions and regulatory inspections.
- Develop and maintain BRR SOPs and training materials.
- Partner with operations to improve documentation accuracy and compliance
Qualifications
- Bachelor's degree required, preferably in a scientific related field.
- A minimum of 5 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
- Equivalent combinations of education, training, and relevant work experience may be considered
- Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
- Hard-working, demonstrated ownership & responsibility;
- Ability to lead, support & empower a team/peers
- Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Requirements
- Bachelor's degree required, preferably in a scientific related field
- A minimum of 5 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
- Equivalent combinations of education, training, and relevant work experience may be considered
- Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
- Hard-working, demonstrated ownership & responsibility
- Ability to lead, support & empower a team/peers
- Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.